Following surgery on the gastrointestinal system in which the bowel undergoes anastomosis, there is an incidence of subsequent leakage from the bowel into the peritoneal cavity which occurs in about 1-8% of patients. The results of this complication are a high morbidity and mortality rate that dramatically affects the patient's prognosis and largely impacts the cost of treatment. Leak detection is generally accomplished by monitoring clinical signs of infection, including white blood cell count, fever, malaise, heart rate, etc. A recognized problem of using clinical signs is that there is a lag between the time the leak occurs and the onset of signs or symptoms. This results in the severity of the problem escalating prior to its detection and the appropriate treatment being instituted.
Imaging modalities, such as fluoroscopy, may be utilized to monitor for leak detection after administering radiopaque dye orally or rectally. Imaging modalities, however, also have limitations of sensitivity and specificity, and require significant resources and cost to perform. Additional leak detection attempts of measuring effluent from drains have demonstrated some success. Limitations of this approach, however, include the inconsistent use of drains due to concomitant complications (e.g., infection, clogging, migration, etc.) and identification of markers from drain fluid may be delayed significantly after the leak occurs.
While devices are available in attempts to identify leaks, it would be advantageous to provide a real time monitoring system for effective early detection of issues associated with a patient's health. Such a device would provide a clinician with a method of evaluating critical predictors of morbidity and mortality in patients in real time following surgery and/or tissue trauma. Acute stage detection would allow for early intervention resulting in improved patient outcomes.